Don’t let ‘the perfect be the enemy of the historic,’ White House says of reconciliation talks
The Food and Drug Administration advisory panel will discuss the Pfizer-BioNTech vaccine only. The proposed dose for children is 10 micrograms, or one-third the adult dose of the Pfizer-BioNTech vaccine.
Moderna on Monday released promising early results for its vaccine in children aged six to 11, but that trial is still ongoing.
Looking at all of the scientific evidence, the advisers will make recommendations to the FDA on this lower dose of the Pfizer-BioNTech vaccine. While the FDA is not required to follow the advisers’ recommendations, the agency usually does.
If advisers for the U.S. Centers for Disease Control and Prevention (CDC) also recommend the vaccine in a meeting next week, it would be rolled out quickly to children five and older across the country, marking a crucial development in the US response to coronavirus.
Last week, almost 118,000 children tested positive for Covid, with a total of more than 1 million new cases among kids in the past six weeks, according to the American Academy of Pediatrics. At least 584 US children have died from Covid.
In addition to protecting children from Covid-19 and its long-term effects, vaccination can also help protect those around them.
“We will not be able to get out of this pandemic without vaccinating children – both for their own sake and for the sake of having overall protection,” Dr Saad Omer, an infectious disease epidemiologist and director of the Yale Institute for Global Health, told the Guardian earlier this month.
FDA weighs coronavirus vaccine for children aged five to 11
Today, advisers for the US Food and Drug Administration (FDA) will consider Pfizer-BioNTech’s application for their Covid-19 vaccine for children aged five to 11.
If it is authorized, it would be the first vaccine available for younger children in the US.
The advisory committee will discuss the vaccine’s effectiveness and the potential risk of side effects like myocarditis, a type of heart inflammation, before making a recommendation to the regulatory agency at the end of the day.
Data from Pfizer-BioNTech, released on Friday, indicate the vaccine is 90.7% effective at preventing symptomatic illness among this age group.
The benefits of vaccination “clearly outweigh” the risks of myocarditis and pericarditis, FDA scientists concluded in an analysis also made public on Friday.